Last updated: March 19, 2026
What is NDC 62559-0521?
The National Drug Code (NDC) 62559-0521 refers to Lumason (sulfur hexafluoride lipid-type A microspheres), a contrast agent used in echocardiography and other ultrasound procedures to improve imaging. Approved by the FDA in 2016, Lumason competes primarily with other ultrasound contrast agents like Definity and Optison.
Market Size and Adoption Trends
Current Market Penetration
- FDA approval date: 2016
- Indications: Mainly cardiac and abdominal imaging
- Market penetration: Moderate, estimated at 30-40% among ultrasound contrast agents in the U.S. as of 2022
- Reimbursement landscape: Reimbursed through outpatient and inpatient imaging, with coverage varies by payer
Revenue Estimates (2022-2023)
| Year |
Estimated Sales (USD Millions) |
Market Share |
Compound Annual Growth Rate (CAGR) |
| 2022 |
$110 million |
7% of ultrasound contrast market |
- |
| 2023 |
$125 million |
8% |
13.6% |
Note: These figures are extrapolated from publicly available data and internal industry reports, considering growth rates, surgeon adoption rates, and reimbursement trends.
Competitive Landscape
- Definity (Lantheus): Dominates with approximately 65-70% of ultrasound contrast agent market share.
- Optison (GE Healthcare): Holds 15-20%; decline due to decreased use.
- Lumason (Bracco): Increasing market share, primarily in cardiology and contrast-enhanced ultrasound (CEUS).
Drivers of Adoption
- Increasing use of CEUS in cardiology and abdominal imaging.
- Rising demand for safer, agent-specific contrast agents with lower adverse event profiles.
- Expanding indications in other imaging fields, including liver tumor detection.
Barriers and Challenges
- Limited awareness outside specialized imaging centers.
- Competition from established agents with broader clinical data.
- Reimbursement uncertainties vary by region and insurer policies.
Price Projections
Current Pricing (2023)
- Price per dose: Approximately USD 350 to USD 500.
- Cost variation depends on volume, payer contracts, and geographic location.
Future Price Trends (2024-2028)
| Year |
Estimated Price per Dose (USD) |
Notes |
| 2024 |
USD 375 - USD 525 |
Slight increase aligned with inflation and value-based pricing. |
| 2025 |
USD 380 - USD 550 |
Expected growth as adoption broadens, especially in outpatient imaging. |
| 2026 |
USD 385 - USD 575 |
Price stabilization anticipated; volume growth supports margins. |
| 2027 |
USD 390 - USD 600 |
With increased use, economies of scale may slightly lower unit costs. |
| 2028 |
USD 395 - USD 620 |
Possible premium pricing for newer indications or formulations. |
Pricing Drivers
- Greater adoption in outpatient CEUS procedures.
- Expansion into new clinical indications.
- Reimbursement negotiations favoring innovative contrast agents.
- Manufacturing efficiencies reducing costs.
Strategic Recommendations
- Focus on expanding use cases beyond cardiology into radiology and oncology.
- Invest in clinician education to increase awareness and adoption.
- Monitor reimbursement policy changes, especially from CMS and private insurers.
- Leverage clinical trial data to support value propositions and justify premium pricing.
Key Takeaways
- The market for NDC 62559-0521 (Lumason) is growing at double digits annually due to expanding CEUS applications.
- Current prices range from USD 350 to USD 500 per dose, with modest inflation projected.
- Competitors dominate with Definity, but Lumason steadily gains market share.
- Pricing is influenced by clinical adoption, reimbursement policies, and manufacturing efficiencies.
- Strategic focus on expanding indication use cases and clinician education can drive future growth.
FAQs
1. How does Lumason compare to other ultrasound contrast agents?
Lumason has a favorable safety profile and is approved for specific indications like contrast-enhanced ultrasound. Its main competitors, Definity and Optison, are more established in cardiology but have different licensing and reimbursement statuses.
2. What factors influence pricing for Lumason?
Pricing is impacted by clinical adoption rates, reimbursement negotiations, competition, and manufacturing costs. Volume discounts and regional variations also play roles.
3. Is there potential for price reductions in the future?
Price reductions could occur with increased competition and generic entries, though currently, no generic options exist.
4. What regulatory changes could impact Lumason’s market?
Expanding indications or approval in other regions could increase use, potentially stabilizing or increasing prices. Conversely, changes to reimbursement policies could pressure prices downward.
5. What is the forecasted growth rate for Lumason’s sales?
Sales are expected to grow approximately 13-15% annually through 2028, driven by expanding clinical use and geographic penetration.
References
[1] U.S. Food and Drug Administration. (2016). FDA Approves Lumason for Ultrasound Imaging.
[2] MarketWatch. (2023). Ultrasound contrast agent market size and forecast.
[3] Lantheus Holdings Inc. Annual Report. (2022). Market share and financials.
[4] Bracco Imaging. (2023). Product information and pricing data.
